FDA Approves Shock Wave Device for Treatment of Diabetic Foot Ulcers


FDA Approves Shock Wave Device for Treatment of Diabetic Foot Ulcers

Summary: The U.S. FDA granted approval to the Dermapace System (Sanuwave Health), a noninvasive extracorporeal shock wave therapy device, for treating chronic, full-thickness diabetic foot ulcers. The device delivers focused acoustic pressure waves to stimulate wound healing through mechanical stress, angiogenesis promotion, and increased blood flow.

Key Highlights:

  • First shock wave device specifically approved for DFU indication
  • Noninvasive, office-based treatment option
  • Targets hard-to-heal chronic diabetic foot ulcers
  • Provides alternative or adjunct to standard wound care

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Keywords: shock wave therapy DFU, Dermapace, extracorporeal shock wave